Clearance Summary
G-PROX EZ ENDOSCOPIC GRASPER received FDA 510(k) clearance under submission number K103688, sponsored by Usgi Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2011-01-14.
- Submission: K103688
- Applicant / Sponsor: Usgi Medical
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-01-14
Classification & Regulation
This clearance is catalogued under FDA product code OCZ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.